Massage for Prostate Cancer-Related Fatigue (mPROSTATE)

Utah System of Higher Education (USHE)

Status and phase: Terminated; Phase 2

Conditions: Prostate Carcinoma

Treatments: Procedure: Swedish Massage Therapy (SMT); Procedure: Light Touch (LT) Control; Other: Waitlist Control (WLC)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05067777

R21CA263453 (U.S. NIH Grant/Contract)

NCI-2021-09613 (Registry Identifier)

HCI144295 (Other Identifier)

P30CA042014 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

This phase II trial investigates the effect of massage in decreasing prostate cancer-related fatigue. Massage therapy has well known health benefits. This trial aims to find out if massage and touch therapies reduce fatigue due to cancer, and to learn if these therapies are better than traditional medicine or psychology for cancer related fatigue.

Full description

With over 15.5 million cancer survivors today in the United States, increased attention is being given to quality of life (QOL) after cancer treatment. Cancer-related fatigue (CRF), "a persistent, subjective sense of physical, emotional, and/or cognitive exhaustion related to cancer or its treatment that is not proportional to recent activity" (National Comprehensive Cancer Network, accessed Oct2020), is the most common and one of the most devastating symptoms among patients with cancer. CRF occurs across the spectrum of cancer types and treatments and has a negative impact on all areas of function, including mood, physical function, work performance, social interaction, family care, cognitive performance, schoolwork, and community activities. CRF can persist for months or years after cancer therapy is completed. CRF has been designated a high-priority research area by the National Cancer Institute (NCI) and is 1 of the 5 highest-priority research areas designated by the NCI Clinical Oncology Research.

This study is a phase II, 3-arm, randomized comparison of single-blinded once-weekly Swedish Massage Therapy (SMT) vs. Light Touch (LT) Control vs. unblinded waitlist control (WLC) for 6 weeks. We chose once-a-week sessions for 6 weeks to match the length of our completed National Center for Complementary and Integrative Health (NCCIH) trial of SMT vs. LT for breast cancer survivors with CRF.

Subjects who complete SMT or LT will be interviewed in person, by telemedicine, or by telephone at 6 and 12 weeks after the last study visit in order to evaluate the sustained effects of SMT and LT. We hypothesize that SMT will have a clinically meaningful benefit in improving fatigue, mood, and quality of life (QOL) in Prostate Cancer (PCa) patients, and that this will correlate with favorable changes in physiological parameters that may underlie CRF. Demographic, medical, clinical, and biological characteristics will be compared between groups of subjects randomized to SMT, LT, or WLC. Any treatment group differences in PCa grade and time since completion of radiation therapy, or baseline Brief Fatigue Inventory (BFI) fatigue score, may affect treatment-related change in fatigue or biological measures related to inflammation, or the post-treatment duration of benefit. While groups are expected to be similar on these characteristics, any variable with a p ≤ 0.10 difference between groups will be considered as a candidate covariate or stratification variable for statistical tests of the study hypotheses.

Enrollment: 28 patients

Sex: Male

Ages: 45+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male subjects aged >= 45 years old

• Histologically confirmed diagnosis of prostate cancer

• Subjects must have completed radiation therapy >= 2 months, prior to registration

• Subjects who have a score > 25 on the Brief Fatigue Inventory (BFI) at screening

• Subjects who are fluent in speaking and reading English

• Based on International Classification of Diseases (ICD)-10 proposed criteria, the patient must have a diagnosis of CRF with evidence from the history, physical exam, and laboratory findings that the fatigue is a consequence of cancer or cancer therapy and not primarily a consequence of any of the following:

  • Comorbid psychiatric disorders

  • Anemia (hemoglobin less than 10 g/dl)

  • Hypothyroidism (thyroid stimulating hormone (TSH) greater than 4.6 micro-international units (uIU)/mL)

  • Uncontrolled pain

  • Any medical or psychiatric condition or medication felt to be clinically contributing to fatigue based on the investigator's history, physical examination, and assessment. These medical circumstances may include:

    • The use of medications such as opioids, sedating anti-histamines, or neuroleptics;
    • Medical problems associated with fatigue: chronic obstructive pulmonary disease, congestive heart failure, renal disease, hepatic dysfunction, uncontrolled autoimmune disease, neurological disorders such as multiple sclerosis or Parkinson's disease, and sleep apnea

• Able to provide informed consent and willing to sign an approved consent form that conforms to federal and institutional guidelines

Exclusion criteria

• Inability to lay prone comfortably for 25 minutes and inability to lay supine comfortably for 25 minutes, given the nature of the massage intervention

• Body-mass index less than 18.5 (kg/m^2)

• Current use of any medications or therapies listed as prohibited in Section 6.6.1.

• Treatment with corticosteroids or other immunosuppressants =< 6 months prior to registration, , unless the medication is necessary to support patient wellbeing and unlikely to negatively impact study aims, per PI judgement..

• Subjects who cannot comply with the protocol for any reason

• Regular use of anti-inflammatory drugs including non-steroidal anti-inflammatory drugs and natural products thought to have anti-inflammatory properties, unless the medication is necessary to support patient wellbeing and unlikely to negatively impact study aims, per PI judgement.

• Change in prescribed dose of medications for anxiety or depression =< 4 weeks prior to registration.

• Change in fluoxetine dose within =< 8 weeks prior to registration

• Subjects meeting criteria for a current substance use diagnosis or current diagnoses of schizophrenia, depression, generalized anxiety disorder, bipolar disorder, dementia, delirium, or obsessive compulsive disorder (OCD)

• Subjects who are actively suicidal or homicidal

• Other conditions or behaviors that, in the opinion of the treating investigator, may negatively impact study participation, including the following:

  • Illicit drug use
  • Shift work
  • Current dieting
  • Excessive regular use of alcohol (more than two 5-ounce glasses of wine or equivalents/day)
  • Any instance of binge drinking (more than 7 drinks in a 24-hour period) =< 6 months prior to registration

• Current and/or past use of massage for the treatment of fatigue.

• Medical, psychiatric, cognitive, or other conditions that may compromise the subject's ability to understand the subject information, give informed consent, comply with the study protocol, or complete the study

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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28 participants in 3 patient groups

Swedish Massage Therapy (SMT)

Experimental group

Description:

Patients receive SMT over 45 minutes once weekly for 6 weeks.

Treatment:

Procedure: Swedish Massage Therapy (SMT)

Light Touch (LT)

Sham Comparator group

Description:

Patients receive LT over 45 minutes once weekly for 6 weeks.

Treatment:

Procedure: Light Touch (LT) Control

Waitlist Control (WLC)

Active Comparator group

Description:

Patients will sit and relax for 45 minutes before completing study assessments at weeks 3 and 6.

Treatment:

Other: Waitlist Control (WLC)